A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Virologic Response at Week 48 - Treated Population
研究概览
简要总结
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
- •Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
- •Prior entecavir and/or tenofovir monotherapy is allowed
- •Subjects must have compensated liver function
排除标准
- •Women who are pregnant or breastfeeding
- •Evidence of decompensated cirrhosis
- •Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
- •Moderate or severe renal impairment
- •Recent history of pancreatitis
- •Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
- •Prior entecavir/tenofovir combination therapy
研究组 & 干预措施
Entecavir + Tenofovir
干预措施: Entecavir (Drug)
Entecavir + Tenofovir
干预措施: Tenofovir (Drug)
结局指标
主要结局
Percentage of Participants With a Virologic Response at Week 48 - Treated Population
时间窗: Week 48
Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.
次要结局
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline(Baseline to Weeks 24, 48, and 96)
- Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population(Weeks 24, 48, 96)
- Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline(Baseline, Weeks 24, 48, and 96)
- Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline(Baseline, Weeks 24, 48, and 96)
- Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population(Day 1 to last dose of study drug plus 5 days; up to Week 96)
- Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population(Week 24, Week 96)
- Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population(Baseline to Weeks 12, 24, 48, 96)
- Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline(Baseline, Weeks 24, 48, 96)
- Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population(Day 1 to last dose of study drug plus 5 days; up to Week 96)
- Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population(Baseline to Weeks 48, 96)